Study Confirms Analytical Precision Of MammaTyper® In Molecular Breast Cancer Typing

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Mainz, Germany, July 12, 2016 / B3C newswire / --  BioNTech Diagnostics GmbH announces the publication of new study data which confirms the high analytical performance of the in vitro diagnostic test kit MammaTyper® (CE labeled IVD) in breast cancer subtyping (1). MammaTyper® allows a precise quantitative determination of the mRNA expression of the biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67), and a molecular subtyping of the tumor tissue according to the St. Gallen guidelines. Thus, MammaTyper® provides an optimized tumor stratification, which is, among other things, a basis for the selection of an effective therapy for each patient (2). According to Professor Arndt Hartmann of Erlangen University Hospital: “The results of the current study show that MammaTyper® delivers reproducible quantitative values for the four biomarkers recommended in the St. Gallen guidelines - independently of individual laboratory conditions.” Dr. Sierk Poetting, Managing Director at BioNTech Diagnostics GmbH, commented: “Once again the MammaTyper® test kit has been proven as an unambiguous technical advance in breast cancer subtyping.” The results of a prospective-retrospective clinical study published in May 2016 demonstrated MammaTyper®´s essential advantages  compared to established methods of detecting biomarkers with regard to disease free survival and overall survival (2).

There has been recent criticism of the established IHC and FISH/CISH methods to determine biomarkers, particularly, with respect to the reproducibility and comparability of the values for the marker Ki-67 (3-7). MammaTyper® technology is based on the molecular determination of the mRNA expression of the four biomarkers from formalin-fixed and paraffin-embedded tumor tissue (FFPE), using the RT-qPCR method (reverse transcription quantitative real time polymerase chain reaction). Earlier studies have shown that this technology possesses essential advantages in comparison to IHC (8-10).

The present study contains an analytical validation of MammaTyper® with respect to various parameters (laboratory site, content of tumor cells in the sample, method of RNA preparation). Therefore FFPE breast cancer samples, covering the whole range of the clinically expected levels of expression of the target genes, were measured under various conditions at three different sites and using different RT-qPCR systems with MammaTyper®.

At a single site, the agreement between the results for the two tested RT-qPCR systems were 100 % for ERBB2, 96.9 % for ESR1, 97.2 % for PGR and 98.6 % for MKI67. MammaTyper® achieved in total a mean correlation between the markers and the sites of more than 96 %. The individual determination of the markers with MammaTyper® was stable up to a 64-fold dilution of a typical clinical sample. The MammaTyper® results were also unaffected by up to 80% of surrounding non-tumor tissue, including in situ carcinoma. 

Dr. Sierk Poetting commented: “This means that the results with the MammaTyper® test kit are stable, even between different sites and under varying conditions. Thus, MammaTyper® allows standardized, precise and reproducible breast cancer subtyping.”

With this accurate, quantitative and reproducible determination of biomarkers, MammaTyper® can help to improve breast cancer diagnosis.

About MammaTyper®
MammaTyper® is a molecular in vitro diagnostic test for quantitative detection of the mRNA expression status of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and of MKI67 (proliferation marker Ki-67) in the tumour tissue of female patients with newly diagnosed invasive breast cancer. The test has been validated for total RNA extracted from tissue specimens or biopsies.

MammaTyper® is used for molecular subtyping of breast cancer tissue according to the St. Gallen classification (2013) in luminal A-like, luminal B-like (HER2 negative), luminal B-like (HER2 positive), HER2 positive (non-luminal) and triple negative (ductal) tumours, and offers the possibility of significantly improving the diagnosis and, ultimately, the treatment of female patients with breast cancer. MammaTyper® is intended for use by a doctor together with further clinical pathological factors. The test is very simple, and can be carried out in any pathology laboratory. The test can be used on all female patients with newly diagnosed invasive breast cancer and provides the results on the same day. With MammaTyper®, BioNTech underlines its commitment to making personalized medicine generally available in the field of cancer treatment.

About BioNTech Group
BioNTech Group, consisting of BioNTech AG and its subsidiaries, is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel antibody checkpoint immunomodulators. BioNTech’s clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held, with Strüngmann Family Office as a majority shareholder, having closed the largest initial financing in the European biopharma sector’s history.

About BioNTech Diagnostics GmbH
BioNTech Diagnostics is a fully-owned subsidiary company within the BioNTech AG Group. The ISO 9001/13485 certified company has extensive product and service offerings ranging from biomarker discovery and validation through molecular screening assays, patient stratification and companion diagnostics to clinical monitoring, all to international regulatory standards. Early detection of diseases that have a high mortality rate and the appropriate selection of therapies are crucial for a successful treatment of patients. BioNTech Diagnostics’ mission is to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.


BioNTech Diagnostics GmbH
Dr. Gerd Hempel
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COMMPartners GmbH Co. KG
Sonja Hinz
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1 Laible M et al. (2016) Technical validation of an RT-qPCR in vitro diagnostic test system for the determination of breast cancer molecular subtypes by quantification of ERBB2, ESR1, PGR and MKI67 mRNA levels from formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer. DOI:10.1186/s12885-016-2476-x (Published online 07 July 2016).
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